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..... | News & Views Newletter edited by Jack Nicholas, cornishpro@aol.com
PSORIATIC ARTHRITIS NEWS AND VIEWS
WOMEN ARE THE HARDIER SEX -WHEN IT COMES TO TOLERATING PAIN, NEW RESEARCH
SAYS She gets a tooth pulled, then drives herself home, makes dinner for four, does the laundry and helps the kids with their homework. He gets a tooth pulled and his universe slams to a halt, as he waits for the pain to go away. Caricatures? Sure. But the debate over who can really stand more pain has been one of the more interesting battles of the sexes, spanning generations. Now, however, new research is bringing that battle into a whole new arena, with strong evidence that the traditionally "weaker" sex may be hardier after all. "I think men have always secretly suspected that in order to go through childbirth a woman has to be pretty tough. Now we have some new science to back up the idea that women may be better able to cope with pain than men -- at least during certain periods of their life," says Dr. James N. Dillard, author of the The Chronic Pain Solution and an assistant clinical professor at Columbia University College of Physicians and Surgeons in New York City. The secret weapon? Estrogen. Produced by the ovaries in peak amounts during the reproductive years, and in lesser amounts later in life, the hormone's influence may extend far beyond a woman's reproductive tract. Its powers may reach straight to the pain centers of the brain. "Although pain is influenced by many factors, it's clear that estrogen plays an important role in the individual response," says Dr. Jon-Kar Zubieta, a neuroscientist at the University of Michigan who has published several studies investigating links between sex hormones and pain. One way estrogen helps women to cope with pain, he says, is by increasing the availability of endorphins -- brain chemicals that help dampen the pain response. When estrogen levels are high, there's an increased number of areas in the brain where endorphins can "park." The more "parking places" available, Zubieta says, the more endorphins there are on call, waiting to flood the body with "feel good" chemicals capable of overriding pain signals. "That's one reason why women can get through the pain of childbirth -- right before they give birth, their estrogen levels are soaring, so their ability to cope with pain is expanded," Zubieta says. Conversely, studies show this same level of pain protection may drop precipitously the closer a woman gets to menopause, a time when estrogen levels can plummet. That fact, says Dillard, may be one reason why so many women begin to feel more aches and pains as they cross the threshold into mid-life. "It's not that they are experiencing more things going wrong with their body, as much as they are experiencing a level of pain they were not feeling before," Dillard explains. As far back as 1993, an animal study published in the journal Pain found that when their ovaries were intact, female rats were far less likely to experience pain than when the ovaries were removed. More recently, studies conducted at the University of Massachusetts revealed that women may have more muscle endurance during exercise than men, thanks again to estrogen, which works to reduce soreness and pain after exertion. Research also shows testosterone levels make little difference in how male rats experience pain, indicating this hormone may not have the same effect on men as estrogen does on women. But when it comes to perceiving pain, it's not just hormones that matter. Dillard says social and cultural conditioning matters as well. "We know that pain pathways go directly into the primitive emotional parts of the brain -- the limbic system. But the degree to which you react to that pain is culturally learned," says Dillard. What can also matter: Previous experience with pain. Because women are preconditioned to at least some degree of monthly menstrual pain, not to mention a pretty hefty level of discomfort during childbirth, Dillard suspects they may react with less alarm when other types of pain occur. And this, he says, may make a big difference when it comes time to have that tooth pulled. "Research has shown that the more upset somebody is about pain -- man or woman -- the more they tend to amplify pain signals and the worse the pain feels," Dillard says. "So, if a woman is used to pain, she will be less alarmed by pain signals, and that leads to better tolerance." The study of gender-based pain is still in its infancy. And while it's beginning to appear as if women may have some biochemical advantages, ironically, women are also more likely to suffer from pain syndrome illnesses -- conditions such as fibromyalgia, lupus, multiple sclerosis and migraine headaches. For more information on chronic pain, visit The American Pain Foundation or the National Foundation for the Treatment of Pain. SOURCES: James N. Dillard, M.D., D.C., C.Ac., assistant clinical professor, Columbia University College of Physicians and Surgeons, clinical adviser, Columbia's Rosenthal Center for Complementary and Alternative Medicine, and director, Complementary Medicine Services, University Pain Center, New York City; Jon-Kar Zubieta, M.D., Ph.D., lead researcher, neuroscientist and director, Psychiatry Division, University of Michigan Depression Center, Ann Arbor *************************************************** NUMBER OF OLDER ADULTS WITH ARTHRITIS EXPECTED TO DOUBLE BY 2030 NEW YORK (Reuters Health) The number of older adults in the US with arthritis or chronic joint symptoms (CJS) is expected to nearly double to 41.1 million by 2030, according to a report released Thursday by the Centers for Disease Control and Prevention. This rise is impressive given the fact that such joint problems are already the leading cause of disability in the US, lead author Dr. J. M. Hootman and colleagues note in the May 30th issue of the CDC's Morbidity and Mortality Weekly Report. The current findings coincide with a report released earlier this month indicating that only 1 in 5 adults with CJS have seen a healthcare provider for these problems. Currently, about 60% of the US population, 65 years of age or older, has arthritis. Despite the high prevalence, chronic joint conditions are expected to become even more common among older adults as the diagnosis and treatment of other chronic diseases improves, leading to increased longevity and a greater opportunity to develop joint problems. To estimate the prevalence of arthritis among older adults in 2030, the researchers applied data from the 2001 Behavioral Risk Factor Surveillance System (BRFSS)--a nationwide survey that included questions about joint symptoms--to projected population data. From 2005 to 2030, the percentage of the US population made up of older adults is expected to increase from 12.9% to 20.0%, the report indicates. If current sex-specific rates remain stable, the number of older adults with arthritis or CJS will increase from 21.4 million to 41.1 million during this period. Estimates through 2025 revealed dramatic differences in disease prevalence based on state residence. For example, 70.3% of older adults in Alabama were predicted to have arthritis or CJS in 2025, compared with only 34.8% of their peers in Hawaii. "Arthritis contributes substantially to disability, poor health-related quality of life, and increased direct and indirect medical costs," according to an accompanying editorial. "Decreasing this impact will require effective public health interventions that improve function, decrease pain, and delay disability among persons with arthritis." *****************************************************
INTERFERON - ALPHA MAY BE HELPFUL IN ARTHRITIS THERAPY In vitro studies indicate that interferon-alpha could have an important therapeutic role in the treatment of arthritis, Canadian researchers report in the May issue of the Journal of Rheumatology. In particular, senior investigator Dr. Eleanor N. Fish, told Reuters Health, "the suggestion from these pilot studies is that a single immunomodulatory agent, interferon-alpha, has the potential to target different destructive events during the pathogenesis of rheumatoid arthritis--inhibiting both the persistent inflammation and the bone and cartilage erosion." Dr. Fish, of the University of Toronto, and colleagues came to these conclusions after studying the effect of the agent on cells from synovial fluid and synovial tissue from patients with osteoarthritis or rheumatoid arthritis. Interferon-alpha treatment resulted in an increase in expression of both interleukin 1 receptor antagonist and soluble tumor necrosis factor receptor in these cells. Furthermore, such treatment of rheumatoid arthritis synovial fluid cells resulted in upregulation of osteoprotegerin gene expression in their T cell fraction. Osteoprotegerin ligand gene expression was not affected. The researchers, who note that they are further exploring this approach in preclinical studies of rheumatoid arthritis, conclude that that interferon-alpha appears to exert its effect "through upregulation of critical cytokine antagonists." J Rheumatol 2003;30:934-940. ***********************************************
GENENTECH, XOMA HALT TESTING OF RAPTIVA FOR ARTHRITIS Genentech Inc. and Xoma Ltd. said on Monday they had stopped testing psoriasis drug Raptiva (efalizumab) as a treatment for rheumatoid arthritis, a use that could have doubled its sales. The companies said the drug did not confer any "net clinical benefit" in a phase II trial involving 240 patients. The U.S. Food and Drug Administration are currently reviewing an application from the companies seeking to market the drug for psoriasis. Genentech and Xoma were hoping to compete in the multi-billion dollar market for rheumatoid arthritis, which affects more than 2 million Americans, with Amgen Inc.'s Enbrel, Johnson & Johnson's Remicade and Abbott Laboratories Inc.'s Humira. Johnson & Johnson is testing its blockbuster arthritis drug Remicade for psoriasis and Amgen Inc. is doing the same with Enbrel. Biogen Inc. in February won FDA approval for its new psoriasis drug, Amevive, making it the first of the new wave of biologic treatments to be approved for psoriasis. Remicade and Enbrel target tumor necrosis factor, while Raptiva and Amevive regulate the binding of T cells to other types of cells. ***************************************** FOLATE SUPPLEMENT IMPROVES RESPONSE TO METHOTREXATE IN RHEUMATOID ARTHRITIS NEW YORK (Reuters Health) A variety of factors, including folate supplementation, influence toxicity, efficacy and other aspects of methotrexate therapy in patients with rheumatoid arthritis, Dutch researchers report in the May issue of the Annals of the Rheumatic Diseases. Dr. M. Hoekstra of Medisch Spectrum Twente, Enschede, and colleague note that although methotrexate is an effective disease-modifying drug in such patients, factors influencing toxicity, efficacy and final dosage are not well defined. To explore factors relevant to daily clinical practice, the researchers studied data from a 48-week clinical trial of methotrexate therapy, starting at 7.5 mg/week, in rheumatoid arthritis patients. The subjects had been randomized to receive folate or placebo supplementation. Analysis showed that folate supplementation was "strongly" related to a lack of hepatotoxicity. A high body mass index (BMI) was related to its occurrence. Prior gastrointestinal (GI) events and being younger were associated with diarrhea. The main reasons for withdrawal from treatment were hepatotoxicity and adverse GI events. These were associated with lack of folate supplementation, BMI, prior GI events and being female. Treatment efficacy was associated with low disease activity at baseline, being male, use of non-steroidal anti-inflammatory drugs and lower creatinine clearance. Overall, the researchers suggests that in light of these findings, patients without prior GI events or a high BMI, who have a calculated creatinine clearance of 50 mL/min or more, "can start with 15 mg/week methotrexate provided that folates are added to the treatment." Ann Rheum Dis 2003;62:423-426. ******************************************************** DYNAMIC MRI CAN DISCRIMINATE ACTIVE FROM INACTIVE RHEUMATOID ARTHRITIS NEW YORK (Reuters Health) Dynamic gadolinium-enhanced MRI scanning of the wrist can accurately assess disease activity in patients with rheumatoid arthritis (RA), according to a report published in the May issue of Arthritis and Rheumatism. MRI is known to be better than conventional radiography at visualizing joint erosions, a pathognomonic finding in RA, the authors noted. However, such erosions are a relatively late finding, and therefore, from a treatment standpoint, it would be useful to have a test that could diagnose RA earlier and discriminate active from inactive disease. Previous reports have suggested that gadolinium is a useful contrast agent for evaluating the synovial membrane, the site where early RA inflammatory changes typically occur. In the current study, Dr. Marco A. Cimmino, from the Universita di Genoa in Italy, and colleagues used dynamic gadolinium-enhanced MRI to image the wrists of 36 patients with RA and 5 healthy control subjects. The RA patients had differing degrees of disease activity. The authors found that dynamic MRI could accurately discriminate controls and patients in remission from patients with active or intermediately active disease. Furthermore, the rate of early enhancement and relative enhancement on MRI were directly related to several clinicopathologic parameters, such as the number of swollen joints, the C-reactive protein level, and the erythrocyte sedimentation rate. The findings show that dynamic MRI can accurately assess disease activity in RA patients, Dr. Cimmino and colleagues conclude. "The technique is easy to perform and devoid of associated adverse events," they note. In addition, "it can be repeated frequently and is an excellent candidate for the ideal method for long-term follow-up of patients with RA." Arthritis Rheum 2003;48:1207-1213. ********************************************** COUNTERFEIT LIPITOR BEWARE The statin drug Lipitor is currently the world's top selling prescription drug. Counterfeit Lipitor is now in circulation in the US. The Food and Drug Administration (FDA) announced that Albers Medical Distributors, Inc., has voluntarily recalled three lots of 90-count bottles of the cholesterol-lowering drug Lipitor and is warning healthcare providers and others that these three lots of counterfeit Lipitor represent a potentially significant risk to consumers. The product was repackaged by Med-Pro, Inc., of Lexington, Neb., and the labels say "Repackaged by: MED-PRO, Inc. Lexington, Neb." in the lower left-hand corner. The following lots are involved in this recall:
20722V - 90-tablet bottles, Expiration 09-2004 FDA is urging healthcare providers and patients alike to check the packaging very carefully before using this product. Patients who have any of the product (labeled as "Repackaged by MED-PRO, Inc.") with these three lot numbers should not take it, and they should return the product to their pharmacies. As part of the FDA's ongoing efforts to investigate and address unscrupulous counterfeiting activities, FDA's Office of Criminal Investigations is investigating the existence of counterfeit Lipitor. Lipitor is a member of a class of cholesterol-lowering drugs that are commonly referred to as "statins." In carrying out its public health mission, FDA regularly conducts investigations and testing to identify and remove from market products that are counterfeit, have been tampered with, or are otherwise unsuitable. FDA supports the activities of legitimate manufacturers, in cooperation with FDA, to inform the public about counterfeit products and how to identify them. The agency is committed to rooting out counterfeiting activity and alerting the public to the existence of counterfeit product. Earlier this month, FDA entered into an agreement with a major pharmaceutical trade association to cooperate more closely on cases of suspected counterfeit products. FDA's investigation into this matter is continuing. Source: FDA Talk Paper # T09-38 **************************************************
ARE DRUG COMPANIES NEXT TARGET AFTER TOBACCO? America's drug industry, which pulls in billions of dollars in profits, is likely to face political attacks similar to those waged against tobacco and big banking, according to analysts. Tactics similar to those used in the past to fight against the tobacco industry and investment banking, such as targeting the harmful effects of smoking or sales and marketing techniques, are now being used in a campaign against the pharmaceutical giants. Two states, Connecticut and New York, are already filing lawsuits against drug companies on the grounds of their sales and marketing practices. Another hot topic in the campaign involves drug pricing. America spends more money on drugs ($149 billion in the year to February, according to a research firm) than Britain, Canada, France, Germany, Italy, Japan and Spain combined. While Americans do consume more drugs than these other countries, drug prices in America are also much higher. Canadian, European and Japanese governments set limits on drug prices, while in America the market has more freedom to set prices. Americans often take the brunt of these expensive drug prices directly. Private health insurers are continually introducing higher co-pays in order to switch costs to consumers, fewer employers are offering prescription-drug benefits to retirees, and those without insurance are faced with particularly high drug prices. Meanwhile, through the Internet Americans are realizing that their drug prices are much higher than those in other countries, and some have turned to Canadian Internet pharmacies as a way to get less expensive drugs. As the drug industry attempts to justify their high prices, several states are looking for ways to lower the prices. For example, Michigan is using an "approved-drug list" as a way to harness discounted prices. The state reportedly saved $45 million on drugs in 2002 by requiring drug companies to discount drugs from the "average wholesale price" in order to be included on the list. Drug companies maintain that America's free market in regard to drug pricing makes the companies more likely to spend R&D money, and that the states' efforts to lower prices is potentially harming research and new drug development. Another widespread perception is that drug companies bribe doctors with free or cheap drugs and spend billions on advertising in order to convince consumers to embrace their expensive and sometimes unnecessary treatments. But, more and more consumers are starting to see drug companies as firms out to profit from the public. While drug companies are spending the same amount on marketing today as they did in 1997, spending on direct-to-consumer advertising has increased from $1.1 billion in 1997 to $3 billion in 2001. Nonetheless, the drug industry argues that drugs lower health care costs overall by reducing the need for more costly treatments such as surgery. However, whether consumers and politicians will continue to accept this argument remains to be seen. Economist April 24, 2003 The following comments are from Dr. Mercola's website, regarding the article published in the April Economist. "For the first time in almost a decade, according to federal health economists, health expenditures outpaced the growth of the economy. This is one amazing statement, but one that is not hard to believe considering retail pharmacies filled 3 billion prescriptions in 2000. The United States currently spends about $1.5 trillion for health care, and the projections are that it will double in less than 10 years. Like the late Senator Everett Dirksen from Illinois was fond of saying when he was referring to the Defense Department budget, a billion dollars here, a billion dollars there, and before you know it you are talking real money. Well, we are talking about a lot more than a few billion dollars; we are talking about nearly $1.5 trillion, an amount that is even beyond Bill Gates' level. Why is it that we are spending huge amounts of money on health care, yet Americans are suffering from more and more chronic illnesses? Obviously the system is not working. We are nowhere near achieving the high levels of health that we could be. More and more people do not have the energy they need to get through the day while millions of others are suffering with painful, crippling diseases--but it does not have to be this way. The tragedy is that rather than spending money on education and methods that can stop disease at its roots, we are spending billions of dollars on drugs and surgery to temporarily cover up the real problem. And what is the real problem? The violation of basic health principles. But, it seems the tide may be turning. More and more Americans are getting fed up with expensive drugs that often cause more harm than good, and the drug companies' deceitful sales and marketing techniques are being exposed for the scams they truly are. In time the truth will naturally come out, but it is my vision and passion to facilitate the spread of truth now." **************************************************** DRUG COMPANIES ENGAGE IN ILLEGAL SALES PRACTICES: U.S. ISSUES WARNING From the New York Times -2003 The government warned drug companies in a compliance guide for the drug industry that many of the techniques they use to sell their drugs risk violating federal fraud and abuse laws. The guide tells drug manufacturers that they must not offer any financial incentives to doctors, hospitals, insurers or pharmacists to encourage or reward the prescribing of particular drugs, as these types of incentives have a high potential for fraud and abuse. Additionally, federal officials oppose the practice of some drug companies of offering gifts and entertainment to doctors. A federal law, known as the antikickback statute, prohibits such payments under Medicare or Medicaid, which combined spend more than $30 billion a year on prescription drugs. However, the practice remains a part of other industries. Marketing practices that increase federal costs, interfere with clinical decisions and lead to the overuse or misuse of drugs were of particular concern, according to the guide. Drug companies did not agree with many of the provisions of the compliance guide, which also states that that drug companies could face prosecution for making payments to health plans or benefit managers, the companies that manage drug benefits, to encourage the use of their drugs. Many health plans and benefit managers compose lists of recommended drugs known as formularies, and sales of drugs on such lists often increase rapidly. Some drug manufacturers therefore offer payments to the people who make up the lists, a practice which may be unlawful. Additionally, the guide warns drug companies that their research and education grants must be separate from their marketing. For example, if a drug company has any influence over the content of a professional education program or the choice of speakers, "there is a risk that the program may be used for inappropriate marketing purposes," according to the guide. Another practice condemned by the guide is when drug companies pay doctors to listen to their sales pitches. This practice is also susceptible to fraud and abuse. Moreover, according to the guide drug manufacturers that give their sales agents excessive bonuses and expense accounts may be intentionally motivating their sales employees to use entertainment or other rewards to promote drug sales. New York Times -2003 ******************************************************** PNEUMONIA VACCINE INEFFECTIVE FOR ELDERLY The pneumonia vaccine, which is recommended for all adults over 65 years of age, does not reduce the risk of contracting the disease, researchers said. Each year, some 350,000 to 620,000 elderly Americans are hospitalized with pneumonia and one-third to one-half have a type known as pneumococcal pneumonia. However, since the pneumococcal pneumonia immunization targets the bacteria that cause the pneumonia and other diseases, it is only effective when the bacteria, Streptococcus pneumoniae, get into the bloodstream. But, the bloodstream form of the disease, pneumococcal bacteremia, is relatively uncommon. Only about 60 out of 100,000 seniors contract this form of the disease. Among this small group, the vaccine reduces the risk of contracting the disease by about 50 percent. In the largest study to date of the pneumococcal pneumonia vaccine, researchers examined medical data on 47,365 people aged 65 years and older from 1998 through 2001. Researchers found that 1,428 people had been hospitalized with pneumonia, 3,061 had pneumonia but did not require hospitalization and 61 people had blood infections due to pneumococcal bacteria. No association was found between pneumococcal vaccination and a reduced risk of pneumonia from any cause, researchers said. The findings did show that the vaccination is effective in preventing disease caused by pneumococcal bacteria, so researchers say the current vaccination recommendations are accurate. Further research is needed to identify vaccines that will be effective in preventing pneumonia overall, researchers noted. Pneumonia affects about 1 million elderly people each year, and pneumonia and influenza combined are the fifth-leading cause of death in older adults. The source for this information came from "The New England Journal of Medicine" ********************************************
ARTHRITIS DRUG RELIEVES SCIATICA PAIN A drug commonly used to ease the pain and inflammation of rheumatoid arthritis may also double as a potential sciatica treatment. A new study shows Remicade (infliximab) effectively reduced leg pain caused by severe sciatica and allowed many suffers to return to normal activities. "These results are very promising for patients suffering from severe sciatica, for which surgery is the only treatment option," says researcher Jaro Karppinen, MD, of Oulu University Hospital in Oulu, Finland, in a news release. "While more research is needed, these findings indicate that infliximab may provide a potential new alternative to help fulfill this unmet medical need." The study appears in the current issue of the journal Spine. Researchers say it's the first time this class of drugs has been studied as a sciatica treatment. The condition can be caused by normal wear and tear on the body, but may also be caused by any sudden pressure on the disc that supports the spine, such as a herniated disc. Symptoms usually include leg pain, weakness, numbness, or a burning or tingling sensation that travels down the leg. Remicade works by reducing the level of a chemical in the body called tumor necrosis factor alpha. Tumor necrosis factor alpha is a key factor in the inflammatory process that occurs in a variety of conditions and is increasingly thought to play a role in sciatica. Remicade is currently approved by the FDA for use in treating rheumatoid arthritis and Crohn's disease. In the study, 10 people who had sciatica caused by a herniated disc were given an intravenous dose of Remicade over two hours. One hour after the infusion, leg pain had been reduced by 50%. Two weeks after treatment, 60% of the patients were free of pain, compared with only 16% of those who received a placebo infusion, and those benefits continued for at least three months. The study also found that within one month after treatment, all of the patients who received Remicade were able to return to work while 38% of the placebo group remained on disability leave. In addition, researchers say none of the patients who received the Remicade sciatica treatment had to undergo surgery for their condition, compared with 15% of the non-treated group. In an editorial that accompanies the study, Bjorn Rydevik, MD, of Sahlgrenska University Hospital in Gothenberg, Sweden, says the results are impressive and "a new era may have been reached with new promising pharmacologic treatment methods for sciatica." Although these results are promising, experts say the findings must first be confirmed by a randomized, controlled trial to look at the long-term safety of using Remicade for sciatica treatment before it can adopted for general use. This information if from the medical journal "Spine" through a news release published by the Orton Rehabilitation Clinic. ******************************************** DRUG EASES PAIN OF ARTHRITIS IN SPINE - ETANERCEPT HELPS PEOPLE WITH ANKYLOSING SPONDYLITIS (HealthDayNews) The drug etanercept eases the painful and debilitating inflammation caused by a form of arthritis called ankylosing spondylitis (AS). That's what a German study in the June issue of Arthritis & Rheumatism found. AS is characterized by inflammation of the joints of the spine. It can affect both men and women, but the majority of people with AS are young men who begin to develop chronic low back pain and general stiffness in their 20s and 30s. AS can fuse the spine and cause serious problems of the hip and other joints. This may occur gradually, but it can also happen rapidly. Because the disease can occur at a young age and because the early symptoms of AS are often overlooked, the condition can be difficult to treat. The common current therapy consists of nonsteroidal anti-inflammatory drugs and physiotherapy. But this approach has limited success in relieving AS-related pain or improving quality of life for people with the disease. This study included 30 males with active AS. They were randomly divided into two groups. For the first six weeks, 14 of them received 25 milligrams of etanercept twice a week while the other 16 received a placebo. For the final six weeks of the study, all 30 men received etanercept. The study found that treatment with etanercept resulted in at least a 50 percent regression of AS activity in 57 percent of the AS patients by the sixth week, compared with 6 percent of the men treated with placebo. After the men receiving the placebo were switched to the drug, 56 percent of them had significant improvement of their AS symptoms. Copyright © 2003 ScoutNews, LLC. ************************************************** Please let me know any areas of specific research that you might like explored. I am always open to your suggestions and constructive criticism. Wouldn't it be nice if whenever we messed up our life we could simply press 'Ctrl Alt Delete' and start all over? Good Health to All,
Jack Nicholas |
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